Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence

• Sponsor: Catalyst Pharmaceuticals, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00730522
• Collaborator: (none)
• Enrollment: 55
• Locations: 8
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 6.9
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Drug: CPP-109 vigabatrin; Drug: Matching Placebo	Phase 2

Detailed Description

This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during Screening/Baseline Phase, lasting up to 4 weeks.

At the conclusion of the Screening/Baseline Phase, subjects meeting all inclusion/exclusion criteria will be randomized to one of two treatment groups: vigabatrin or placebo. Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period. Subjects will be scheduled for clinic visits 3 times per week for efficacy and/or safety assessments during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects will return for follow up visits at Weeks 13, 16, 20 and 24.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 CPP-109 vigabatrin tablets	Drug: CPP-109 vigabatrin; tablets, bid for 12 weeks; Other Names: GVG gamma-vinyl GABA
Placebo Comparator: 2 Matching Placebo Tablets	Drug: Matching Placebo; tablets, bid, 12 weeks

Outcome Measures

Primary Outcome Measures

1. The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). [Weeks 11-12]

Secondary Outcome Measures

1. • Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase. [Weeks 1-12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Able to understand the study and provide written informed consent.

• Male or female at least 18 years of age.

• Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for methamphetamine dependence as major diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).

• Provides at least one urine specimen which is positive for methamphetamine according to a rapid screening test.

• Seeking treatment for methamphetamine dependence.

• Have normal visual fields.

• Be in generally good health based on history, physical examination and laboratory findings.

• If female of childbearing potential, use acceptable contraceptive methods

Exclusion Criteria:

• Has current dependence on any psychoactive substance other than methamphetamine, alcohol, nicotine, or cannabinoid or physiologic dependence on alcohol requiring medical detoxification.

• Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory values.

• Has history of serious cardiovascular reaction to methamphetamine.

• Has clinically significant cardiovascular impairment, abnormal ECG or uncontrolled hypertension.

• Be under court or other governmental agency (e.g. social services) mandate to obtain treatment or requiring outside urine monitoring.

• Be enrolled in an opiate substitution treatment program within 2 months of randomization.

• Has ever taken vigabatrin in the past.

• Is pregnant or lactating.

• Has clinically significant ophthalmologic disease, which would preclude safety monitoring, is undergoing treatment for ocular disease or intends to have any ocular surgery or procedure performed during the time of their participation in the trial.

• Has received a drug with known major organ toxicity, including retinotoxicity.

• Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.

• Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North County Clinical Research (NCCR)	Oceanside	California	United States
2	South Bay Treatment Center	San Diego	California	United States
3	Addiction Pharmacology Research Laboratory, St. Luke's Hospital	San Francisco	California	United States
4	START Research and Treatment	Kansas City	Missouri	United States
5	Creighton University Medical Center	Omaha	Nebraska	United States
6	Behavioral Health Research Center of the Southwest	Albuquerque	New Mexico	United States
7	Pahl Pharmaceutical Research	Oklahoma City	Oklahoma	United States
8	Pillar Research	Dallas	Texas	United States

Sponsors and Collaborators

• Catalyst Pharmaceuticals, Inc.

Investigators

• Study Director: Charles W Gorodetzky, MD, PhD, Catalyst Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catalyst Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00730522
• Other Study ID Numbers: CPP-02001
• First Posted: Aug 8, 2008
• Last Update Posted: Dec 9, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Catalyst Pharmaceuticals, Inc.: Methamphetamine; Dependency; Addiction; vigabatrin
• Additional relevant MeSH terms: Vigabatrin

Study Results

Participant Flow

Arm/Group Title	Vigabatrin Tablets	Matching Placebo Tablets
Arm/Group Description	CPP-109 vigabatrin tablets (3.0 gm/day) for 12 weeks including 2 week dose escalation CPP-109 vigabatrin: tablets, bid for 12 weeks	Matching Placebo Tablets for 12 weeks on a schedule to match active arm Matching Placebo: tablets, bid
Period Title: Overall Study
STARTED	28	27
COMPLETED	28	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Vigabatrin	Matching Placebo	Total
Arm/Group Description	CPP-109 vigabatrin tablets CPP-109 vigabatrin: tablets, bid for 12 weeks	Matching Placebo Tablets Matching Placebo: tablets, bid, 12 weeks	Total of all reporting groups
Overall Participants	28	27	55
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 100%	27 100%	55 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	44	42	43
Sex: Female, Male (Count of Participants)
Female	19 67.9%	18 66.7%	37 67.3%
Male	9 32.1%	9 33.3%	18 32.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	28 100%	27 100%	55 100%
Methamphetamine substance dependence (Count of Participants)
Count of Participants [Participants]	28 100%	27 100%	55 100%

Outcome Measures

1. Primary Outcome

Title	The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12).
Time Frame	Weeks 11-12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vigabatrin	Placebo
Arm/Group Description	CPP-109 vigabatrin tablets CPP-109 vigabatrin: tablets, bid for 12 weeks	Matching Placebo Tablets Matching Placebo: tablets, bid, 12 weeks
Measure Participants	28	27
Count of Participants [Participants]	4 14.3%	2 7.4%

2. Secondary Outcome

Title	• Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase.
Time Frame	Weeks 1-12

Outcome Measure Data

Analysis Population Description

Data were not collected due to early study termination.

Arm/Group Title	CPP-109 Vigabatrin Treated Group	Matching Placebo Treated Group
Arm/Group Description	Participants who received CPP-109 (vigabatrin) tablets CPP-109 vigabatrin: tablets, bid for 12 weeks	Participants who received Matching Placebo Tablets Matching Placebo: tablets, bid, 12 weeks
Measure Participants	0	0

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Vigabatrin		Placebo
Arm/Group Description	CPP-109 vigabatrin tablets CPP-109 vigabatrin: tablets, bid for 12 weeks		Matching Placebo Tablets Matching Placebo: tablets, bid, 12 weeks
All Cause Mortality
	Vigabatrin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/27 (0%)
Serious Adverse Events
	Vigabatrin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/28 (7.1%)		0/27 (0%)
General disorders
Hernia obstructive	1/28 (3.6%)		0/27 (0%)
Injury, poisoning and procedural complications
fracture	1/28 (3.6%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Vigabatrin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/28 (85.7%)		23/27 (85.2%)
Eye disorders
Eye pruritus	1/28 (3.6%)		0/27 (0%)
Gastrointestinal disorders
Vomiting	0/28 (0%)		1/27 (3.7%)
Toothache	1/28 (3.6%)		1/27 (3.7%)
Nausea	1/28 (3.6%)		2/27 (7.4%)
Constipation	1/28 (3.6%)		0/27 (0%)
Diarrhoea	2/28 (7.1%)		0/27 (0%)
Abdominal distension	1/28 (3.6%)		0/27 (0%)
Flatulence	1/28 (3.6%)		0/27 (0%)
General disorders
Fatigue	0/28 (0%)		1/27 (3.7%)
Infections and infestations
Nasopharyngitis	2/28 (7.1%)		1/27 (3.7%)
Influenza	0/28 (0%)		1/27 (3.7%)
Tooth infection	1/28 (3.6%)		0/27 (0%)
Musculoskeletal and connective tissue disorders
Groin pain	0/28 (0%)		1/27 (3.7%)
Osteoarthritis	1/28 (3.6%)		0/27 (0%)
Neck pain	1/28 (3.6%)		0/27 (0%)
Myalgia	0/28 (0%)		1/27 (3.7%)
Nervous system disorders
Dizziness	1/28 (3.6%)		2/27 (7.4%)
Headache	3/28 (10.7%)		3/27 (11.1%)
Hypoaesthesia	1/28 (3.6%)		0/27 (0%)
Psychiatric disorders
Depression	0/28 (0%)		2/27 (7.4%)
Anxiety	0/28 (0%)		2/27 (7.4%)
Somnolence	0/28 (0%)		1/27 (3.7%)
Paranoia	1/28 (3.6%)		0/27 (0%)
Confusional state	1/28 (3.6%)		0/27 (0%)
Reproductive system and breast disorders
Menstruation irregular	0/28 (0%)		1/27 (3.7%)
Ovarian Cyst ruptured	1/28 (3.6%)		0/27 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion	1/28 (3.6%)		1/27 (3.7%)
Pharyngolaryngeal pain	0/28 (0%)		1/27 (3.7%)
Skin and subcutaneous tissue disorders
Urticaria	1/28 (3.6%)		0/27 (0%)
Dermatitis	1/28 (3.6%)		0/27 (0%)
Hyperhidrosis	0/28 (0%)		1/27 (3.7%)

Limitations/Caveats

Study terminated early due to other failed indication for product and only limited data collected without complete analysis. CPP-109 stopped all development in substance dependent indications. Therefore, not able to summarize most data, as not available.

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.