ARRIVE- EU: Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Study Details
Study Description
Brief Summary
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aripiprazole IM depot injection Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary. |
Drug: Aripiprazole (Abilify®) IM Depot Injection
400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014.
Other Names:
Drug: Oral aripiprazole
Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day).
|
Outcome Measures
Primary Outcome Measures
- Comparison of Inpatient Psychiatric Hospitalization Rates [Retrospective period Months 4-6; Prospective period Months 4-6]
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
Secondary Outcome Measures
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score [Baseline, Week 24]
The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.
- Change From Baseline in PANSS Positive and Negative Subscale Scores [Baseline, Week 24]
The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.
- Clinical Global Impression of Severity (CGI-S) Score [Baseline, Week 24]
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients.
- Clinical Global Impression of Improvement (CGI-I) Score [Baseline, Week 24]
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects who are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure.
-
Male and female subjects 18 to 65 years of age, inclusive
-
Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and a history of the illness for at least 1 year (12 months)
-
Subjects who in the investigator's judgment would benefit from extended treatment with a long-acting injectable formulation
-
Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study
-
Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase Subjects who have shown response to previous antipsychotic treatment.
-
Subjects who understand the nature of the trial and are able to follow the protocol requirements.
Exclusion Criteria:
-
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial.
-
Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial.
-
Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication.
-
Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
-
Subjects with a history of hypersensitivity to antipsychotic agents.
-
Subjects deemed intolerant of receiving injectable treatment.
-
Subjects who have received electroconvulsive therapy within the last 7 months prior to screening.
-
Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
-
Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
-
Subjects requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the Informed Consent Form (ICF) or during the screening period.
-
Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening.
-
Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening.
-
Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine.
-
Treatment with long-acting injectable antipsychotics in which the last dose was within 7 months prior to screening.
-
Subjects who have not been treated with oral antipsychotics for 7 months prior to screening.
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Subjects who have a significant risk of committing suicide
-
Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
-
Sexually active males and females who will not commit to utilizing birth control during the trial and for up to 180 days following the trial.
-
Abnormal laboratory or physical examination results indicating a condition which may interfere with the results of the study or pose a safety risk to the subject.
-
Subjects who have previously enrolled in an aripiprazole IM depot clinical study or who have participated in any clinical trial with an investigational agent within the past 30 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brugge | Belgium | 8310 | ||
| 2 | Bruxelles | Belgium | 1160 | ||
| 3 | Kortenberg | Belgium | 3070 | ||
| 4 | Liège | Belgium | 4000 | ||
| 5 | Lovech | Bulgaria | 5500 | ||
| 6 | Novi Iskar | Bulgaria | 1282 | ||
| 7 | Pazardjik | Bulgaria | 4400 | ||
| 8 | Tzerova Koria | Bulgaria | 5047 | ||
| 9 | Penticton | British Columbia | Canada | V2A 4M4 | |
| 10 | Chatham | Ontario | Canada | N7M 5L9 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
- Study Director: Tim Peters-Strickland, Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 31-11-284
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | This study included a Tolerability Assessment Phase A (if applicable), an Open-Label Aripiprazole IM Depot Phase B and an Open-Label Aripiprazole IM Depot Extension Phase C. |
| Arm/Group Title | Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection |
|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary. |
| Period Title: Oral Aripirazole (Phase A) | |
| STARTED | 19 |
| COMPLETED | 8 |
| NOT COMPLETED | 11 |
| Period Title: Oral Aripirazole (Phase A) | |
| STARTED | 19 |
| COMPLETED | 3 |
| NOT COMPLETED | 16 |
| Period Title: Oral Aripirazole (Phase A) | |
| STARTED | 3 |
| COMPLETED | 0 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary. |
| Overall Participants | 30 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
43.9
(12.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
10
33.3%
|
| Male |
20
66.7%
|
Outcome Measures
| Title | Comparison of Inpatient Psychiatric Hospitalization Rates |
|---|---|
| Description | The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. |
| Time Frame | Retrospective period Months 4-6; Prospective period Months 4-6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated. |
| Arm/Group Title | Aripiprazole IM Depot Injection | Standard of Care |
|---|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary. | Patients who received oral antipsychotic treatment as standard of care in clinical practice. |
| Measure Participants | 0 | 0 |
| Title | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score |
|---|---|
| Description | The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. |
| Arm/Group Title | Aripiprazole IM Depot Injection |
|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary. |
| Measure Participants | 0 |
| Title | Change From Baseline in PANSS Positive and Negative Subscale Scores |
|---|---|
| Description | The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. |
| Arm/Group Title | Aripiprazole IM Depot Injection |
|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary. |
| Measure Participants | 0 |
| Title | Clinical Global Impression of Severity (CGI-S) Score |
|---|---|
| Description | The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. |
| Arm/Group Title | Aripiprazole IM Depot Injection |
|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary. |
| Measure Participants | 0 |
| Title | Clinical Global Impression of Improvement (CGI-I) Score |
|---|---|
| Description | The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated. |
| Arm/Group Title | Aripiprazole IM Depot Injection |
|---|---|
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary. |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Oral Aripiprazole (Phase A) | Aripiprazole IM Depot (Phase B) | Aripiprazole IM Depot (Phase C) | |||
| Arm/Group Description | Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. | In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary. | Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary. | |||
All Cause Mortality |
||||||
| Oral Aripiprazole (Phase A) | Aripiprazole IM Depot (Phase B) | Aripiprazole IM Depot (Phase C) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Oral Aripiprazole (Phase A) | Aripiprazole IM Depot (Phase B) | Aripiprazole IM Depot (Phase C) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Hepatobiliary disorders | ||||||
| Drug-induced liver injury | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Psychiatric disorders | ||||||
| Schizophrenia | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Oral Aripiprazole (Phase A) | Aripiprazole IM Depot (Phase B) | Aripiprazole IM Depot (Phase C) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/19 (21.1%) | 10/19 (52.6%) | 1/3 (33.3%) | |||
| Cardiac disorders | ||||||
| Palpitations | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Gastrointestinal disorders | ||||||
| Flatulence | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| General disorders | ||||||
| Fatigue | 1/19 (5.3%) | 2/19 (10.5%) | 0/3 (0%) | |||
| Irritability | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Infections and infestations | ||||||
| Bronchitis | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Aspartate aminotransferase increased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Blood creatine phosphokinase increased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Blood glucose increased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Blood triglycerides increased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Gamma-glutamyltransferase increased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Weight decreased | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Diabetes mellitus | 0/19 (0%) | 1/19 (5.3%) | 1/3 (33.3%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Musculoskeletal pain | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Nervous system disorders | ||||||
| Somnolence | 1/19 (5.3%) | 1/19 (5.3%) | 0/3 (0%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 3/19 (15.8%) | 3/19 (15.8%) | 0/3 (0%) | |||
| Psychotic disorder | 0/19 (0%) | 1/19 (5.3%) | 0/3 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Medical Affairs |
|---|---|
| Organization | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Phone | 800-562-3974 |
- 31-11-284