Eletriptan Provides Consistent Migraine Relief: Results Of A Within-Patient Multiple-Dose Study

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01859481

Collaborator

(none)

971

Enrollment

148

Locations

Arms

Duration (Months)

6.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of headache response at 2 hours for active treated attacks for increasing dose.

Condition or Disease	Intervention/Treatment	Phase
Migraine Without Aura Migraine With Aura	Drug: Placebo Drug: Eletriptan HBr 40 mg Drug: Eletriptan HBr 80 mg	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

971 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicentre, Dose Optimisation Study to Assess the Consistency of Efficacy of Eletriptan for the Treatment of Migraine (With and Without Aura)

Study Start Date :

Mar 1, 2000

Actual Primary Completion Date :

Mar 1, 2002

Actual Study Completion Date :

Mar 1, 2002

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Experimental: Eletriptan HBr 40 mg	Drug: Eletriptan HBr 40 mg All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
Experimental: Eletriptan HBr 80 mg	Drug: Eletriptan HBr 80 mg All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Drug: Placebo

All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.

Experimental: Eletriptan HBr 40 mg

Drug: Eletriptan HBr 40 mg

Experimental: Eletriptan HBr 80 mg

Drug: Eletriptan HBr 80 mg

Outcome Measures

Primary Outcome Measures

Consistency of headache response (3 responses out of 3 active treated attacks) . Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. [24 weeks]

Secondary Outcome Measures

Consistency of headache response (2 responses out of 3 active treated attacks). Headache response was defined as migraine headache pain of moderate or severe intensity pre dose becoming basent or mild within 2 hours post dose. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male and Female subjects in good general health, aged 18 to 65 years.
Subjects should meet IHS diagnostic criteria for migraine with or without aura.
Based on past history, subjects should expect to suffer at least one acute attack of migraine with or without aura, each 6 weeks

Exclusion Criteria:

Known coronary-artery disease, clinically significant arrhythmia, heart failure, or uncontrolled hypertension.
Pregnant or lactating women.
Clinically significant electrocardiogram abnormalities at screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eeuwfeestkliniek	Antwerpen		Belgium	2018
2	A.Z. Sint Jan	Brugge		Belgium	8000
3	Cliniques Universitaires St Luc	Bruxelles		Belgium	1200
4	C.H.U. de Charleroi	Charleroi		Belgium	6000
5	Hopital de La Citadelle	Liege		Belgium	4000
6	Faculty Hospital U Svety Anny	Brno		Czechia	65691
7	Neurologika Klinika F.N.	Hradec Kralove		Czechia	50005
8	Pain Centrum	Prague 2		Czechia	12 850
9	1St Medical Faculty of the Charles University	Prague 2		Czechia	12000
10	Arhus Kommunehospital	Arhus C		Denmark	8000
11	Kas Glostrup	Glostrup		Denmark	2600
12	Korsgaard, Anne G. (Private Practice)	Odense C		Denmark	5000
13	Peter Staehr	Olstykke		Denmark	3650
14	Asbjorn Ziebel	Roskilde		Denmark	4000
15	Hopital de Rangueil	Toulouse	Cedex 04	France	31403
16	Veyrie-Courtade	Toulouse	Tououse	France	31500
17	C.H.U.R Bretonneau	Tours Cedex	Tours	France	37044
18	Kubler Altkirch	Altkirch		France	68130
19	Marcombes Angouleme	Angouleme		France	16000
20	Houdart Anzin	Anzin		France	59416
21	Groupe Pellegrin Tripode	Bordeaux Cedex		France	33076
22	Siboni Carcassonne	Carcassonne		France	11000
23	Hopital Louis Mourier	Colombes Cedex		France	92701
24	Cormier Laval	Laval		France	53000
25	Hopital Salengro	Lille		France	59037
26	Hopital Louis Pradel	Lyon Cedex 03		France	69394
27	Hopital Pasteur	Nice Cedex 1		France	06200
28	Private Practice	Orleans		France	45000
29	Hopital Cochin	Paris Codex 14		France	75679
30	Delfiner Paris	Paris		France	75015
31	Hopital Lariboisiere	Paris		France	75475
32	Vaunaize Reims (Ds For Oc)	Reims		France	51100
33	Vaunaize Reims	Reims		France	51100
34	Hopital Charles Nicolle	Rouen		France	76031
35	Hospital Bellevue	Saint Etienne Cedex 2		France	42055
36	Bouchacourt Toulon	Toulon		France	83 000
37	Lemarquis Toulon	Toulon		France	83000
38	Mick Voiron	Voiron		France	38500
39	Private Practice	Berlin		Germany	10117
40	Private Practice	Berlin		Germany	12687
41	Private Practice (Guenther Schumann)	Bochum		Germany	44805
42	Private Practice	Bochum		Germany	44807
43	Private Practice	Eckernfoerde		Germany	24340
44	Private Practice	Goettingen		Germany	37073
45	Private Practice	Hamburg		Germany	22149
46	Private Practice	Oldenburg		Germany	26131
47	Fachklinik Fuer Neurologie Dietenbronn Gmbh	Schwendi		Germany	88475
48	Private Practice (Dr. Renate Kreyer)	Stade		Germany	21680
49	Neurology Clinic of Chania	Souda	Chania,crete	Greece	73100
50	General Athens State Hospital	Athens		Greece	GR 156 69
51	Saint Dimitrios Hospital	Thessaloniki		Greece	GR 546 34
52	Peterfy Teaching Hospital	Budapest		Hungary	1076
53	Semmelweis University	Budapest		Hungary	1083
54	Szent-Imre Hospital	Budapest		Hungary	1115
55	Jahn Ferenc Hospital	Budapest		Hungary	1201
56	Uzsoki Hospital	Budapest		Hungary	1426
57	University of Debrecen, Medical and Health Science Centre, Medical School	Debrecen		Hungary	4012
58	Kenezy County Hospital	Debrecen		Hungary	4034
59	Universita Degli Studi Di Modena-Policlinico Dipartimento Di Medicina Interna	Modena	Emilia-romagna	Italy	41100
60	Fondazione Istituto Neurologico Casimiro Mondino Istituto Di Ricovero E Cura A Carattere Scientifico	Pavia	Lombardia	Italy	27100
61	Universita' Di Bologna	Bologna		Italy	40123
62	Poliambulatorio Salus	Brescia		Italy	25100
63	Universita' Degli Studi Di Cagliari - Presidio Osp.S.Giovanni Di Dio	Cagliari		Italy	09124
64	Azienda Vittorio Emanuele	Catania		Italy	95100
65	Clinica Neurologica	L'aquila-coppito		Italy	67100
66	Policlinico Universitario	Messina		Italy	98125
67	Centro Cefalee Irccs "C. Besta"	Milano		Italy	20133
68	Universita Di Padova	Padova		Italy	35128
69	Centro Cefalee	Parma		Italy	43100
70	Clinica Neurologica, Universita Di Perugia	Perugia		Italy	06126
71	Centro Cefalee - Neuromed	Pozzilli (isernia)		Italy	86077
72	Ospedale S. Eugenio	Roma		Italy	00100
73	Centro Cefalee	Torino		Italy	10126
74	Ospedale Regionale Torrette	Torrette DI Ancona (AN)		Italy	60020
75	Ospedale Maggiore	Trieste		Italy	34126
76	Ospedale S. Bortolo	Vicenza		Italy	36100
77	Bosch Medicentrum (Locatie Willem Alexander Ziekenhuis)	's-hertogenbosch		Netherlands	5223GV
78	Sint Lucas Andreas Ziekenhuis (Location: St.Lucas)	Amsterdam		Netherlands	1061 AE
79	Gelre Ziekenhuis (Location: Lukas)	Apeldoorn		Netherlands	7334 DZ
80	Ziekenhuis Gooi-Noord	Blaricum		Netherlands	1261 AN
81	Ignatius Ziekenhuis Breda	Breda		Netherlands	4818 CK
82	Gelderse Vallei Ziekenhuis	EDE		Netherlands	6711 PV
83	Scheperziekenhuis	Emmen		Netherlands	7824 AA
84	Atrium Heerlen	Heerlen		Netherlands	6419 PC
85	St. Streekziekenhuis Midden Twente	Hengelo (OV)		Netherlands	7555DL
86	Ikazia Ziekenhuis	Rotterdam		Netherlands	3083 AN
87	Sint Elisabeth Ziekenhuis	Venray		Netherlands	5801 CE
88	Lage Land Ziekenhuis	Zoetermeer		Netherlands	2725 NA
89	Sentralsykehuset I Akershus	Nordbyhagen		Norway	1474
90	Volvat Medisinske Senter	Oslo		Norway	0303
91	Strandquist, Dr. Stein Bror	Tonsberg		Norway	3111
92	Hospital Garcia Da Orta	Almada		Portugal	2800
93	Centro Hospitalar de Coimbra	Coimbra		Portugal	3000
94	Hospital S.Joao	Porto		Portugal	4000
95	Consorci Hospitalari Del Parc Tauli	Sabadell	Barcelona	Spain	08208
96	Hospital Universitario de Puerto Real	Puerto Real	Cadiz	Spain	11510
97	Fundacion Hospital Alcorcon	Alcorcon	Madrid	Spain	28922
98	Hospital de Galdakao	Galdakao	Vizcaya	Spain	48960
99	Hospital Torrecardenas	Almeria		Spain	04009
100	Hospital Del Sagrado Corazon	Barcelona		Spain	08029
101	Hospital General Universitari Vall D�Hebron	Barcelona		Spain	08035
102	Hospital General Yag�	Burgos		Spain	09005
103	Hospital Nuestra SE�Ra de Alarcos	Ciudad Real		Spain	13002
104	Hospital Ciudad de Jaen	Jaen		Spain	23007
105	Hospital Universitari de Lleida Arnau de Vilanova	Lleida		Spain	25198
106	Hospital Ramon Y Cajal	Madrid		Spain	28034
107	Hospital Universitario San Carlos	Madrid		Spain	28040
108	Hospital Virgen de La Victoria	Malaga		Spain	29010
109	Hospital General Universitario J. M. Morales Meseguer	Murcia		Spain	30008
110	Hospital General de Asturias	Oviedo		Spain	33006
111	Hospital Na Sa de Aranzazu	San Sebastian		Spain	20014
112	Hospital Nuestra SE�Ra de Valme	Sevilla		Spain	41014
113	Hospital Clinico Universitario La Fe	Valencia		Spain	46009
114	Hospital General Universitario	Valencia		Spain	46014
115	Fritsla Vardcentral	Fritsla		Sweden	510 29
116	Migranklinik-Goeteborg	Goeteborg		Sweden	SE-411 17
117	Lanssjukhuset Halmstad	Halmstad		Sweden	301 85
118	Viktoriakliniken	Halmstad		Sweden	30246
119	Neurologsektionen, Lasarettet	Helsingborg		Sweden	251 87
120	Neuro Kliniken, Helsingborg	Helsingborg		Sweden	25221
121	Sjocrona Vardcentral	Hoganas		Sweden	263 26
122	Huddinge Universitetssjukhus	Huddinge		Sweden
123	Kistahalsan Ab	Kista		Sweden	164 40
124	Lund Lakarmottagningen	Lund		Sweden	221 21
125	Medicin Kliniken, Universitetssjukhuset	Lund		Sweden	22185
126	Lakargruppen Gustaf Adolf	Malmo		Sweden	211 36
127	Previa Ab Sigtunahalsan	Marsta		Sweden	195 30
128	Oxelohalsan	Oxelosund		Sweden	613 30
129	Bankhalsan	Stockholm		Sweden	105 34
130	Lakarhuset Odenplan	Stockholm		Sweden	113 22
131	Ostermalmshalsan	Stockholm		Sweden	11486
132	St Gorans Sjukhus	Stockholm		Sweden	SE-112 81
133	Tyresohalsan Huslakare Ab (Ds For Oc)	Tyreso		Sweden	135 21
134	Tyresohalsan Huslakare Ab	Tyreso		Sweden	135 21
135	Kronobergskliniken	Vaexjoe		Sweden	SE-352 34
136	Centrallasarettet	Vasteras		Sweden	721 89
137	Vasterviks Sjukhus	Vastervik		Sweden	593 81
138	Novakliniken	Ystad		Sweden	271 39
139	Cukurova University Medical Faculty	Adana		Turkey	01330
140	Karadeniz Technical University Medical Faculty	Trabzon		Turkey	61080
141	Ahepa University Hospital
142	Foretagshalsovarden Linden
143	Huslakargruppen
144	Limhamns Lakargrupp, Tarnan
145	Medicinskt Centrum
146	Sentralsjukehuset I Hedmark
147	Sint Anna Ziekenhuis
148	Vardcentralen