Trial Outcomes & Findings for Two Rizatriptan Prescribing Portions for Treatment of Migraine (NCT NCT00397254)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

197 participants

Primary outcome timeframe

6 months

Results posted on

2010-06-08

Participant Flow

3-month Baseline Period occurred prior to randomization to Clinical Limit or Formulary Limit groups. 42 subjects discontinued from total enrollment of 197: (2) Adverse Event (AE), (10) Lost to Follow Up (LFU), (11) Withdrew consent, (1) Pregnancy, (16) Failed to meet Inclusion/Exclusion at Visit 4 Randomization, (2) Other

Participant milestones

Participant milestones
Measure	Rizatriptan 27 Tablets - Clinical Limit Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Overall Study STARTED	79	76
Overall Study COMPLETED	77	74
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Rizatriptan 27 Tablets - Clinical Limit Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Two Rizatriptan Prescribing Portions for Treatment of Migraine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Period - Rizatriptan 9 Tablets n=197 Participants Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	197 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	42 years n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	197 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Number of Days With Migraine	2.666 Days Standard Deviation 1.297	2.738 Days Standard Deviation 1.313

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Number of Migraine Attacks	4.855 Migraine attacks Standard Deviation 2.093	4.399 Migraine attacks Standard Deviation 1.548

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Percentage of Responders (50% decrease in attack frequency) of Formulary Limit Group versus Percentage of Responders (50% decrease in attack frequency) in Clinical Limit Group

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Percentage of Responders	7.79 Percentage of Participants	2.70 Percentage of Participants

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Average Attack Duration	11.569 Hours Standard Deviation 8.188	12.930 Hours Standard Deviation 9.192

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

4-Point Headache Severity Scale (0 = No Pain / 1 = Mild Pain / 2 = Moderate Pain / 3 = Severe Pain)

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Headache Severity of All Attacks	1.50 Units on a scale Interval 1.0 to 2.76	1.59 Units on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Formulary Limit Group versus percentage of attacks with elimination of all associated symptoms at 2 hours post-treatment in Clinical Limit Group

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Percentage of Attacks With Symptom Elimination at 2 Hours	58.35 Percentage of attacks	56.60 Percentage of attacks

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Percentage of attacks with mild, moderate or severely impaired ability to perform activities pre-treatment with return to normal function at 2 hours post-dose in Formulary Limit Group versus Clinical Limit Group

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Percentage of Attacks With Return to Normal Ability to Perform Activities at 2 Hours Post-dose	50.74 Percentage of attacks	48.67 Percentage of attacks

SECONDARY outcome

Timeframe: 6 months

Population: 197 enrolled in Baseline(BL). Analysis of BL Characteristics on 197. 42 discontinued (2 Adverse Event(AE),10 Lost to followup(LFU),11 Withdrew consent,1 Pregnant,16 Failed randomization criteria,2 Other). 155 randomized. 4/155 LFU. 151 in analysis(77 Clinical Limit/74 Formulary Limit). 143 completed all visits(74 Clinical Limit/69 Formulary Limit).

Participants with one or more Adverse Experiences (AEs) in Formulary Limit Group versus Clinical Limit Group collected from time patient provided informed consent until return at Visit 7 or through 14 days post-dosing of the last dose of study medication if serious adverse experience. Defined as any unfavorable and unintended change in structure, function, or chemistry of the body temporally associated with use of provided product whether or not considered related to use of the product. Includes any worsening of a preexisting condition temporally associated with use of provided product.

Outcome measures

Outcome measures
Measure	Rizatriptan 27 Tablets - Clinical Limit n=77 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "clinical limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month.	Rizatriptan 9 Tablets - Formulary Limit n=74 Participants Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a "formulary limit" of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month.
Adverse Experiences	18 Participants	24 Participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

M.E. Beach

Clinvest

Phone: 417-841-3618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator is free to publish results of it's part of the study in collaboration with the other investigators subsequent to the multicenter publication issued by Clinvest. Principal Investigator (PI) may publish results of it's data with copy of any manuscript for review to Clinvest 60 days prior to submission for publication.
Publication restrictions are in place

Restriction type: OTHER