Trial Outcomes & Findings for Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine (NCT NCT02828020)

NCT ID: NCT02828020

Last Updated: 2019-01-03

Results Overview

Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1672 participants
• Primary outcome timeframe: Baseline (Predose) to 2 hours after initial dose
• Results posted on: 2019-01-03

Participant Flow

Participant milestones

Measure	Placebo 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Treatment Period STARTED	559	556	557
Treatment Period Safety Population: Received Study Drug	485	466	485
Treatment Period COMPLETED	479	457	479
Treatment Period NOT COMPLETED	80	99	78
Safety Follow-up Period STARTED	480	458	480
Safety Follow-up Period COMPLETED	460	440	461
Safety Follow-up Period NOT COMPLETED	20	18	19

Reasons for withdrawal

Measure	Placebo 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Treatment Period Adverse Event	3	1	1
Treatment Period Withdrawal of Consent	10	14	9
Treatment Period Lost to Follow-up	21	24	18
Treatment Period Lack of Qualifying Event	44	53	43
Treatment Period Pregnancy	0	2	0
Treatment Period Protocol Violation	2	4	7
Treatment Period Other Miscellaneous Reasons	0	1	0
Safety Follow-up Period Withdrawal of Consent	10	8	7
Safety Follow-up Period Lost to Follow-up	9	8	11
Safety Follow-up Period Protocol Violation	0	2	1
Safety Follow-up Period Other Miscellaneous Reasons	1	0	0

Baseline Characteristics

Efficacy, Safety, and Tolerability Study of Oral Ubrogepant in the Acute Treatment of Migraine

Baseline characteristics by cohort

Measure	Placebo n=559 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=556 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=557 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Total n=1672 Participants Total of all reporting groups
Age, Continuous	41.1 years STANDARD_DEVIATION 11.9 • n=5 Participants	40.2 years STANDARD_DEVIATION 12.0 • n=7 Participants	40.7 years STANDARD_DEVIATION 12.4 • n=5 Participants	40.7 years STANDARD_DEVIATION 12.1 • n=4 Participants
Sex: Female, Male Female	491 Participants n=5 Participants	493 Participants n=7 Participants	479 Participants n=5 Participants	1463 Participants n=4 Participants
Sex: Female, Male Male	68 Participants n=5 Participants	63 Participants n=7 Participants	78 Participants n=5 Participants	209 Participants n=4 Participants
Race/Ethnicity, Customized White	471 Participants n=5 Participants	459 Participants n=7 Participants	447 Participants n=5 Participants	1377 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	65 Participants n=5 Participants	77 Participants n=7 Participants	88 Participants n=5 Participants	230 Participants n=4 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	60 Participants n=5 Participants	67 Participants n=7 Participants	66 Participants n=5 Participants	193 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	499 Participants n=5 Participants	489 Participants n=7 Participants	491 Participants n=5 Participants	1479 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Predose) to 2 hours after initial dose

Population: Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).

Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.

Outcome measures

Measure	Placebo n=456 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=422 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=448 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose	11.8 percentage of participants	19.2 percentage of participants	21.2 percentage of participants

PRIMARY outcome

Timeframe: Baseline (Predose) to 2 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.

Outcome measures

Measure	Placebo n=454 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=420 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=448 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose	27.8 percentage of participants	38.6 percentage of participants	37.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Predose) to 2 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.

Outcome measures

Measure	Placebo n=456 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=422 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=448 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose	49.1 percentage of participants	60.7 percentage of participants	61.4 percentage of participants

SECONDARY outcome

Timeframe: 2 to 24 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.

Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.

Outcome measures

Measure	Placebo n=447 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=413 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=434 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose	20.8 percentage of participants	36.3 percentage of participants	38.0 percentage of participants

SECONDARY outcome

Timeframe: 2 to 24 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.

Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.

Outcome measures

Measure	Placebo n=452 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=418 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=441 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose	8.6 percentage of participants	12.7 percentage of participants	15.4 percentage of participants

SECONDARY outcome

Timeframe: 2 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.

Outcome measures

Measure	Placebo n=456 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=423 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=448 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose	31.4 percentage of participants	40.7 percentage of participants	45.8 percentage of participants

SECONDARY outcome

Timeframe: 2 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.

Outcome measures

Measure	Placebo n=456 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=423 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=448 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose	47.1 percentage of participants	57.9 percentage of participants	54.5 percentage of participants

SECONDARY outcome

Timeframe: 2 hours after initial dose

Population: mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.

Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.

Outcome measures

Measure	Placebo n=456 Participants 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=423 Participants 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=448 Participants 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose	62.3 percentage of participants	70.2 percentage of participants	69.2 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ubrogepant 50 mg

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Ubrogepant 100 mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=485 participants at risk 2 placebo-matching ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take 2-placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 50 mg n=466 participants at risk 1 ubrogepant 50 mg tablet and 1 placebo-matching ubrogepant 50 mg tablet, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.	Ubrogepant 100 mg n=485 participants at risk 2 Ubrogepant 50 mg tablets, orally for treatment of a qualifying migraine attack. Participants had the option to take a second dose, 2 placebo-matching ubrogepant tablets or rescue medication, orally 2 to 48 hours after initial treatment.
Infections and infestations Appendicitis	0.00% 0/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.21% 1/466 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.21% 1/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events
Nervous system disorders Seizure	0.00% 0/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.00% 0/466 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.21% 1/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.21% 1/466 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.00% 0/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events
Cardiac disorders Pericardial effusion	0.00% 0/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.21% 1/466 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events	0.00% 0/485 • From first dose through 30 days after the last dose of study drug (approximately 30 days) Safety population, all participants who received at least 1 dose of investigational product was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER