Trial Outcomes & Findings for Reliability of Rimegepant or Triptans for the Acute Treatment of Migraine (NCT NCT06412965)

NCT ID: NCT06412965

Last Updated: 2025-01-13

Results Overview

Physicians responded as "Yes" or "No" if participants failed to achieve pain freedom within 2 hours post dose. In this outcome measure, number of participants were reported according to physicians' responses. Participant who failed to achieve pain freedom at 2 hours post dose on more than half of the occasion were reported in this outcome measure.

Recruitment status

COMPLETED

Target enrollment

528 participants

Primary outcome timeframe

2 hours post dose (from the data collected retrospectively)

Results posted on

2025-01-13

Participant Flow

Data was extracted from Adelphi Real World (ARW) Migraine VII Disease Specific Programme (DSP) 2022 database. Participants diagnosed with migraine and prescribed rimegepant or triptans as an acute treatment for their migraine in the US, were recruited into the Migraine VII DSP US between May 2022 and November 2022. This retrospective observational study comprised secondary data analysis of DSP data.

Participant milestones

Participant milestones
Measure
Rimegepant
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Overall Study
STARTED
91
437
Overall Study
COMPLETED
91
437
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Number Analyzed = Number of participants who were evaluable and had non-missing values.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rimegepant
n=91 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=437 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Total
n=528 Participants
Total of all reporting groups
Age, Continuous
39.01 Years
STANDARD_DEVIATION 13.11 • n=91 Participants
38.98 Years
STANDARD_DEVIATION 13.4 • n=437 Participants
38.99 Years
STANDARD_DEVIATION 13.34 • n=528 Participants
Sex: Female, Male
Female
66 Participants
n=89 Participants • Number Analyzed = Number of participants who were evaluable and had non-missing values.
309 Participants
n=437 Participants • Number Analyzed = Number of participants who were evaluable and had non-missing values.
375 Participants
n=526 Participants • Number Analyzed = Number of participants who were evaluable and had non-missing values.
Sex: Female, Male
Male
23 Participants
n=89 Participants • Number Analyzed = Number of participants who were evaluable and had non-missing values.
128 Participants
n=437 Participants • Number Analyzed = Number of participants who were evaluable and had non-missing values.
151 Participants
n=526 Participants • Number Analyzed = Number of participants who were evaluable and had non-missing values.
Race/Ethnicity, Customized
White/Caucasian
65 Participants
n=91 Participants
304 Participants
n=437 Participants
369 Participants
n=528 Participants
Race/Ethnicity, Customized
African American
12 Participants
n=91 Participants
65 Participants
n=437 Participants
77 Participants
n=528 Participants
Race/Ethnicity, Customized
Native American
1 Participants
n=91 Participants
1 Participants
n=437 Participants
2 Participants
n=528 Participants
Race/Ethnicity, Customized
Asian (Indian subcontinent)
0 Participants
n=91 Participants
8 Participants
n=437 Participants
8 Participants
n=528 Participants
Race/Ethnicity, Customized
South-East Asian
1 Participants
n=91 Participants
8 Participants
n=437 Participants
9 Participants
n=528 Participants
Race/Ethnicity, Customized
Asian (other)
2 Participants
n=91 Participants
8 Participants
n=437 Participants
10 Participants
n=528 Participants
Race/Ethnicity, Customized
Hispanic / Latino / Latina
8 Participants
n=91 Participants
38 Participants
n=437 Participants
46 Participants
n=528 Participants
Race/Ethnicity, Customized
Middle Eastern
2 Participants
n=91 Participants
8 Participants
n=437 Participants
10 Participants
n=528 Participants

PRIMARY outcome

Timeframe: 2 hours post dose (from the data collected retrospectively)

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Physicians responded as "Yes" or "No" if participants failed to achieve pain freedom within 2 hours post dose. In this outcome measure, number of participants were reported according to physicians' responses. Participant who failed to achieve pain freedom at 2 hours post dose on more than half of the occasion were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Rimegepant
n=86 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=384 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Who Failed to Achieve Pain Freedom Within 2 Hours Post Dose (Physician Perspective)
Yes
23 Participants
167 Participants
Number of Participants Who Failed to Achieve Pain Freedom Within 2 Hours Post Dose (Physician Perspective)
No
63 Participants
217 Participants

PRIMARY outcome

Timeframe: 2 hours post dose (from the data collected retrospectively)

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Number of participants who reported migraine pain freedom within 2 hours post dosing in 0 out of every 5 attacks, 1 out of every 5 attacks, 2 out of every 5 attacks, 3 out of every 5 attacks, 4 out of every 5 attacks, or 5 out of every 5 attacks were recorded. Success was defined as responses to '4 out of every 5 attacks' or '5 out of every 5 attacks' combined. In this outcome measure, number of participants with 'success' were reported as per participants' responses. Participant who reported migraine pain freedom (success) at 2 hours post dose on more than half of occasion were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Rimegepant
n=29 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=106 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Who Reported Migraine Pain Freedom (Success) Within 2 Hours Post Dose (Participants Perspective)
22 Participants
67 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study.

Physicians' satisfaction with current acute treatment for migraine was recorded and classified as extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied and extremely dissatisfied. In this outcome measure number of participants were reported per each category according to physicians' responses.

Outcome measures

Outcome measures
Measure
Rimegepant
n=91 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=437 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Extremely satisfied
55 Participants
103 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Satisfied
31 Participants
276 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Slightly satisfied
2 Participants
33 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Neither satisfied nor dissatisfied
0 Participants
12 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Slightly dissatisfied
2 Participants
10 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Dissatisfied
1 Participants
2 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Physician Perspective)
Extremely dissatisfied
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Physicians' reported reasons for lack of satisfaction with current acute treatment. In this outcome measure number of participants were reported per each reason according to physicians' responses. There could be more than 1 reason for lack of satisfaction per participant.

Outcome measures

Outcome measures
Measure
Rimegepant
n=5 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=58 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Number of side effects experienced
0 Participants
8 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Lack of efficacy
3 Participants
26 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Slow onset of action
0 Participants
13 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Efficacy diminished over time
0 Participants
17 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Severity of side effects experienced
0 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Mode of administration
0 Participants
2 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
The number of prescribed acute treatments
0 Participants
2 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
The treatment is costly for the participant
2 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Physician Perspective)
Other
1 Participants
7 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Participants' satisfaction with current acute treatment for migraine was recorded and classified as extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied and extremely dissatisfied. In this outcome measure number of participants were reported per each category according to participants' responses.

Outcome measures

Outcome measures
Measure
Rimegepant
n=29 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=103 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Extremely satisfied
17 Participants
23 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Satisfied
11 Participants
57 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Slightly satisfied
0 Participants
11 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Neither satisfied nor dissatisfied
1 Participants
5 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Slightly dissatisfied
0 Participants
5 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Dissatisfied
0 Participants
1 Participants
Number of Participants Classified Based on Satisfaction With Current Acute Treatment (Participants Perspective)
Extremely dissatisfied
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Participants' reported reasons for lack of satisfaction with current acute treatment. In this outcome measure, number of participants were reported per each reason according to participants' responses. There could be more than 1 reason for lack of satisfaction per participant.

Outcome measures

Outcome measures
Measure
Rimegepant
n=1 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=11 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
Other
0 Participants
3 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
It only reduces my migraine pain by half
0 Participants
3 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
It reduces my migraine pain by less than half
0 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
It does not work quickly enough
1 Participants
5 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
It does not work as well as it used to
0 Participants
5 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
The number of side effects I experience
0 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
The severity of the side effects I experience
0 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
I am not happy with the way I have to take it
0 Participants
2 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
I find it difficult to know when to take it
1 Participants
3 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
I have too many different acute treatments to take
0 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
I worry about becoming dependent on it
0 Participants
1 Participants
Number of Participants Classified Based on Reasons for Lack of Satisfaction With Current Acute Treatment (Participants Perspective)
It costs me too much money
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Participants responded about their willingness to continue use of acute treatment and responses were classified as definitely yes, probably yes, do not know, probably not, definitely not. Willingness to continue was defined as responses to: 'Definitely yes' or 'Probably yes' combined. Unwillingness to continue was defined as responses to 'Probably not' and 'Definitely not' combined. In this outcome measure number of participants were reported according to participants' responses.

Outcome measures

Outcome measures
Measure
Rimegepant
n=29 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=94 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Willing to Continue Use of Acute Treatment (Participants Perspective)
Willing to continue
28 Participants
92 Participants
Number of Participants Willing to Continue Use of Acute Treatment (Participants Perspective)
Unwilling to continue
1 Participants
2 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number Analyzed" signifies number of participants evaluable for specified rows.

mTOQ6 was participants reported questionnaire and participants had to respond on following 6 items: 1) "Are you able to quickly return to your normal activities (i.e., work, family, leisure, social activities) after taking your migraine medication?"; 2) "After taking your migraine medication, are you pain free within 2 hours for most attacks?"; 3) "Does one dose of your migraine medication usually relieve your headache and keep it away for at least 24 hours?"; 4) "Is your migraine medication well tolerated?"; 5) "Are you comfortable enough with your migraine medication to be able to plan your daily activities?"; and 6) "After taking your migraine medication, do you feel in control of your migraines enough so that you feel there will be no disruption to your daily activities?". Each item had following responses: never, rarely, less than half the time and half the time or more.

Outcome measures

Outcome measures
Measure
Rimegepant
n=30 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=109 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 5 · Never
0 Participants
1 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 1 · Never
1 Participants
1 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 1 · Rarely
1 Participants
7 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 1 · Less than half the time
1 Participants
14 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 1 · Half the time or more
27 Participants
86 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 2 · Never
0 Participants
2 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 2 · Rarely
2 Participants
8 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 2 · Less than half the time
1 Participants
15 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 2 · Half the time or more
27 Participants
84 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 3 · Never
0 Participants
2 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 3 · Rarely
1 Participants
6 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 3 · Less than half the time
2 Participants
14 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 3 · Half the time or more
27 Participants
86 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 4 · Never
0 Participants
0 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 4 · Rarely
1 Participants
7 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 4 · Less than half the time
0 Participants
11 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 4 · Half the time or more
29 Participants
88 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 5 · Rarely
2 Participants
10 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 5 · Less than half the time
1 Participants
14 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 5 · Half the time or more
27 Participants
83 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 6 · Never
0 Participants
2 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 6 · Rarely
2 Participants
5 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 6 · Less than half the time
2 Participants
17 Participants
Number of Participants Classified According to Responses Per Item of Migraine Treatment Optimization Questionnaire (mTOQ6)
Item 6 · Half the time or more
26 Participants
82 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

In this outcome measure number of participants were classified based on timing/when they took acute treatment as follows: 1) before any sign of a migraine attack, but in anticipation of one starting; 2) at the first sign of a migraine attack (before the pain started); 3) when the pain started; 4) after the pain had started and participant had an idea of pain's severity.

Outcome measures

Outcome measures
Measure
Rimegepant
n=29 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=104 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Number of Participants Classified Based on Timing They Took Acute Prescription Treatment
Before any sign of a migraine attack, but in anticipation of one starting
3 Participants
10 Participants
Number of Participants Classified Based on Timing They Took Acute Prescription Treatment
At the first sign of a migraine attack (before the pain started)
21 Participants
76 Participants
Number of Participants Classified Based on Timing They Took Acute Prescription Treatment
When the pain started
4 Participants
15 Participants
Number of Participants Classified Based on Timing They Took Acute Prescription Treatment
After the pain has started and participant had an idea of how severe it was
1 Participants
3 Participants

PRIMARY outcome

Timeframe: Over the last 3 months prior completing the survey

Population: Analysis population included all participants who met eligibility criteria was included in this study. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

In this outcome measure mean of number of days per month participants took acute prescription treatment were recorded.

Outcome measures

Outcome measures
Measure
Rimegepant
n=29 Participants
Participants who in a real world setting under routine clinical practice were prescribed rimegepant for the acute treatment of migraine and their data was observed retrospectively in this study.
Triptans
n=108 Participants
Participants who in a real world setting under routine clinical practice were prescribed triptans for the acute treatment of migraine and their data was observed retrospectively in this study.
Mean of Number of Days Per Month Participants Took Acute Prescription Treatment
3.29 Days per month
Standard Deviation 1.71
4.04 Days per month
Standard Deviation 4.82

Adverse Events

Rimegepant

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Triptans

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER